Description and Brand Names

US Brand Name

Descriptions

Chloroquine is used to prevent and treat malaria. It is also used to treat liver infection caused by protozoa (extraintestinal amebiasis).

Chloroquine belongs to a group of medicines known as antimalarials. It works by preventing or treating malaria, a red blood cell infection transmitted by the bite of a mosquito.

Malaria transmission occurs in large areas of Central and South America, Hispaniola, sub-Saharan Africa, the Indian subcontinent, Southeast Asia, the Middle East, and Oceania. Country-specific information on malaria can be obtained from the Centers for Disease Control and Prevention (CDC), or from the CDC's web site at http://www.cdc.gov/travel/yellowbk.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, chloroquine is used in certain patients with the following medical conditions:

Arthritis in children.

High levels of calcium in the blood associated with sarcoidosis.

Rheumatoid arthritis.

Systemic lupus erythematosus.

Various skin disorders.

For patients taking chloroquine for arthritis or lupus:

This medicine must be taken regularly as ordered by your doctor in order for it to help you. It may take up to several weeks before you begin to feel better. It may take up to 6 months before you feel the full benefit of this medicine.

If your symptoms of arthritis do not improve within a few weeks or months, or if they become worse, check with your doctor.

This product is available in the following dosage forms:

Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of chloroquine to prevent and treat malaria in children. However, safety and efficacy of chloroquine to treat extraintestinal amebiasis have not been established in children.

Geriatric

Although appropriate studies on the relationship of age to the effects of chloroquine have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of chloroquine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving chloroquine.

Pregnancy

Information about this chloroquine-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine

Aurothioglucose

Bepridil

Cisapride

Dronedarone

Levomethadyl

Mesoridazine

Pimozide

Piperaquine

Sparfloxacin

Terfenadine

Thioridazine

Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide

Ajmaline

Alfuzosin

Amiodarone

Amisulpride

Amitriptyline

Amoxapine

Anagrelide

Apomorphine

Aprindine

Aripiprazole

Arsenic Trioxide

Asenapine

Astemizole

Azimilide

Azithromycin

Bretylium

Buserelin

Chloral Hydrate

Chlorpromazine

Cimetidine

Citalopram

Clarithromycin

Clomipramine

Clozapine

Crizotinib

Dabrafenib

Dasatinib

Deferasirox

Delamanid

Desipramine

Deslorelin

Dibenzepin

Disopyramide

Dofetilide

Dolasetron

Domperidone

Doxepin

Droperidol

Enflurane

Erythromycin

Escitalopram

Fingolimod

Flecainide

Fluconazole

Fluoxetine

Foscarnet

Gatifloxacin

Gemifloxacin

Gonadorelin

Goserelin

Granisetron

Halofantrine

Haloperidol

Halothane

Histrelin

Hydroquinidine

Ibutilide

Iloperidone

Imipramine

Isoflurane

Isradipine

Ivabradine

Ketoconazole

Lapatinib

Leuprolide

Levofloxacin

Lidoflazine

Lopinavir

Lumefantrine

Mefloquine

Methadone

Metronidazole

Mifepristone

Moxifloxacin

Nafarelin

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Paliperidone

Pazopanib

Pentamidine

Perflutren Lipid Microsphere

Pirmenol

Pixantrone

Posaconazole

Prajmaline

Probucol

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Rabies Vaccine

Ranolazine

Risperidone

Salmeterol

Saquinavir

Sematilide

Sertindole

Sevoflurane

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Spiramycin

Sulfamethoxazole

Sultopride

Sunitinib

Tedisamil

Telithromycin

Tetrabenazine

Toremifene

Trazodone

Trifluoperazine

Trimethoprim

Trimipramine

Triptorelin

Vandetanib

Vardenafil

Vasopressin

Vemurafenib

Vinflunine

Voriconazole

Zolmitriptan

Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ciprofloxacin

Cyclosporine

Kaolin

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

Praziquantel

Proguanil

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Allergy to 4-aminoquinoline compounds (eg, hydroxychloroquine) or

Eye or vision problems (eg, retinal or visual field changes) caused by 4-aminoquinoline compounds—Should not be used in patients with these conditions.

Blood or bone marrow problems or

Eye or vision problems (eg, macular degeneration, retinopathy) or

Hearing problems or

Muscle weakness or

Porphyria or

Psoriasis or

Stomach or bowel problems—Use with caution. May make these conditions worse.

Liver disease—Use with caution. The effects may be increased because of the slower removal of chloroquine from the body.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of serious side effects.

Take this medicine with meals or milk to lessen stomach upset, unless otherwise directed by your doctor.

For patients taking chloroquine to prevent malaria:

Your doctor will want you to start taking this medicine 1 to 2 weeks before you travel to an area where there is a chance of getting malaria. This will help you to see how you react to the medicine. Also, it will allow time for your doctor to change to another medicine if you have a reaction to this medicine.

Also, you should keep taking this medicine while you are in the area and for 4 weeks after you leave the area. No medicine will protect you completely from malaria. However, to protect you as completely as possible, it is important to keep taking this medicine for the full time your doctor ordered. Also, if fever develops during your travels or within 2 months after you leave the area, check with your doctor immediately.

If you are taking this medicine to help keep you from getting malaria, keep taking it for the full time of treatment. If you already have malaria, you should still keep taking this medicine for the full time of treatment even if you begin to feel better after a few days. This will help to clear up your infection completely. If you stop taking this medicine too soon, your symptoms may return.

Chloroquine works best when you take it on a regular schedule. For example, if you taking it once a week to prevent malaria, it is best to take it on the same day of each week. Make sure that you do not miss any doses. If you have any questions about this, check with your doctor.

If you are also taking kaolin or antacids, take them at least 4 hours before or after using chloroquine. If you are also taking ampicillin, take it at least 2 hours before or after using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For prevention of malaria:

Adults—500 milligrams (mg) once every week.

Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 milligram (mg) per kilogram (kg) of body weight per week.

For treatment of malaria:

Adults—At first, 1000 milligrams (mg) once a day. Then, 500 mg 6 to 8 hours after the first dose, and 500 mg on the second and third days of treatment.

Children—Dose is based on body weight and must be determined by your doctor. The dose is 10 milligram (mg) per kilogram (kg) of body weight. Then, 5 mg per kg of body weight taken 6 hours after the first dose. Then, 5 mg per kg of body weight taken 24 hours after the first dose, and 5 mg per kg of body weight taken 36 hours after the first dose.

For treatment of liver infection caused by protozoa:

Adults—1000 milligrams (mg) once a day, taken for 2 days. This is followed by 500 mg once a day for at least 2 to 3 weeks.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits. This is to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects. Your doctor may want to check your blood, eyes, ears, knee or ankle reflexes during or after using this medicine.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Chloroquine may cause vision problems. It may also cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not able to see well. If these reactions are especially bothersome, check with your doctor.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may cause extrapyramidal disorders (eg, dystonia, dyskinesia, tongue protrusion, torticollis). Check with your doctor right away if you have the following symptoms after using the medicine: difficulty in speaking, drooling, loss of balance control, muscle trembling, jerking, or stiffness, restlessness, shuffling walk, stiffness of the limbs, twisting movements of the body, or uncontrolled movements, especially of the face, neck, and back.

Using this medicine for a long time may cause muscle weakness. Check with your doctor right away if you have muscle weakness while using this medicine.

Children are very sensitive to this medicine, and accidental overdoses have occurred with small amounts of chloroquine. Keep this medicine out of the reach of children.

Check with your doctor right away if you have continuing ringing or buzzing or other unexplained noise in the ears or hearing loss while using this medicine.

While you are being treated with chloroquine, do not have any immunizations (eg, rabies vaccine) without your doctor's approval.

Avoid drinking alcohol while you are using this medicine.

Malaria is spread by the bites of certain kinds of infected female mosquitoes. If you are living in or will be traveling to an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

If possible, avoid going out between dusk and dawn because it is at these times that mosquitoes most commonly bite.

Remain in air-conditioned or well-screened rooms to reduce contact with mosquitoes.

Wear long-sleeved shirts or blouses and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.

Apply insect repellent, preferably one containing DEET, to uncovered areas of the skin from dusk through dawn when mosquitoes are out.

If possible, sleep in a screened or air-conditioned room or under mosquito netting preferably netting coated or soaked with pyrethrum, to avoid being bitten by malaria-carrying mosquitoes.

Use mosquito coils or sprays to kill mosquitoes in living and sleeping quarters during evening and nighttime hours.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. When this medicine is used for short periods of time, side effects usually are rare. However, when it is used for a long time and/or in high doses, side effects are more likely to occur and may be serious.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

blurred vision

chest pain

chills

confusion

cough

diarrhea

difficulty with swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Chest discomfort

cold clammy skin

decreased urine

drowsiness

dry mouth

fainting

fast, slow, or irregular heartbeat

fast, weak pulse

increased thirst

lightheadedness, dizziness or fainting

loss of appetite

muscle pain or cramps

numbness or tingling in the hands, feet, or lips

sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Change in hair color

hair loss

increased sensitivity of the skin to sunlight

redness or other discoloration of the skin

severe sunburn

Incidence not known

Abdominal or stomach cramps

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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